Upper Limb Function Following Transcutaneous Electrical Spinal Cord Stimulation in Individuals With Hemiplegic Stroke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Fugl-Meyer Test of Upper Extremity Function (FMUE)
研究概览
简要总结
This study aims to evaluate the feasibility and impact of transcutaneous electrical stimulation of the spinal cord (TESS) on the recovery of post-stroke individuals who have upper limb hemiparesis. It will compare outcomes measures between individuals who receive upper limb task specific training with TESS and individuals who receive task specific training of the upper limb with Sham, or fake, TESS.
详细描述
Upper limb (UL) hemiparesis is the most common post-stroke disability. Currently, there is no treatment used in the clinic that has shown to be efficacious for 75% of individuals who have moderate to severe UL hemiparesis. There are no interventions for individuals with moderate to severe hemiparesis that have demonstrated superiority in comparison to standard care. These stroke patients often have increased spasticity and muscle weakness, resulting in chronic upper limb dysfunction. We are proposing an alternative strategy to improve upper limb function after stroke: transcutaneous electrical stimulation of the spinal cord (TESS). Our objective is to evaluate the feasibility and neural effects of transcutaneous spinal stimulation plus task specific training in a two-arm study with three time points (pre-/post-intervention and follow-up). We will recruit 14 chronic post-stroke participants who will receive 15 sessions of either TESS plus task specific training or Sham TESS plus task specific training. Our long-term research goal is to use TESS as a therapeutic strategy, combined with task specific training, to improve upper limb impairment and function in chronic stroke survivors. Our central hypothesis is that excitation of spinal circuitry by spinal stimulation will result in more effective motor control that will improve volitional upper limb movement (as compared to sham stimulation plus task specific training). This hypothesis is based on published work in cervical spinal cord injury.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
During treatment sessions, both the experimental group and the active comparator group receive the same task specific training protocol as well as don the TESS system. For the active comparator group, the TESS will be turned on to a threshold level of sensation. The participant will be told that the stimulation is being lowered to a below-threshold level, at which point it will be turned off for the rest of the session. This will allow the participants to remain blinded. It is not possible to perform the protocol with blinded treatment therapists. The blinded evaluator is not present during the treatment sessions and will not be told which group the participant is in.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •able and willing to give written consent and comply with study procedures
- •at least 6 months post-stroke
- •hemiplegia secondary to stroke
- •UE Fugle Meyer Assessment <35
- •not currently receiving regular occupational therapy services
- •participant has received clearance from physician to participate in study
- •participant has at least a rudimentary comprehension of English
排除标准
- •botox injection in upper extremity within the last 4 months
- •modified ashworth score of 4 in any joint of the affected limb
- •pregnant or nursing
- •using a powered, implanted cardiac device for monitoring or support of heart function (i.e. pacemaker, defibrillator, or LVAD), or anti-spasticity implantable pumps, or cochlear implants
- •unhealed bone fractures
- •severe contractures in the upper extremities
- •active cancer or cancer remission less than 5 years
- •orthopedic dysfunction, injury, or surgery that would impact the individual's ability to use the upper extremities
- •recent procedure or operation of the spinal cord within the past year
- •traumatic brain injury or neurological conditions that would impact the study
- •skull fracture that has developed within the past 6 months
- •non-English speakers
结局指标
主要结局
Fugl-Meyer Test of Upper Extremity Function (FMUE)
时间窗: Session 1 (Week 1): Baseline Evaluation, Session 18 (Week 7): Post-intervention Evaluation, Session 20 (Week 15): Follow-up Evaluation
The FMUE is an impairment scale that addresses both synergy and isolated movements of the upper limb. The subscales include reflex movements, flexor synergy, extensor synergy, movements out of synergy, combining synergies, wrist, hand, and coordination subscales. The total score ranges from 0 to 66 with higher scores indicating greater function.
Modified Ashworth Scale (MAS)
时间窗: Session 1 (Week 1): Baseline Evaluation, Session 18 (Week 7): Post-intervention Evaluation, Session 20 (Week 15): Follow-up Evaluation
The MAS is a test of muscle spasticity and increases in muscle tone. The scores range from 0-4 for each test item, depending on the increase in muscle tone when completing quick movement, or resting muscle tone.
Grip Strength
时间窗: Session 1 (Week 1): Baseline Evaluation, Session 18 (Week 7): Post-intervention Evaluation, Session 20 (Week 15): Follow-up Evaluation
Grip strength will be an outcome measure measured via the Jamar Dynamometer. The procedure will consist of 3 tests of maximum grip strength force. Participants will be given \~30 seconds to 1 minute of rest time for each hand in between tests. The individual will maintain \~90 degrees of elbow flexion, 0 degrees of shoulder flexion, and a neutral wrist position while completing the testing.
Chedoke Arm & Hand Activity Index (CAHAI-9)
时间窗: Session 1 (Week 1): Baseline Evaluation, Session 18 (Week 7): Post-intervention Evaluation, Session 20 (Week 15): Follow-up Evaluation
The CAHAI 9 is a test of bimanual function. There are nine activities including opening a jar, pouring water, drawing a line with a ruler, buttoning a shirt, using the telephone, wringing out a washcloth, applying toothpaste to a toothbrush, cutting food, and drying one's back with a bath towel. The scale ranges from 1 to 7 for each test item and are graded by the amount of use of the affected hand.
Canadian Occupational Performance Measure (COPM)
时间窗: Session 1 (Week 1): Baseline Evaluation, Session 18 (Week 7): Post-intervention Evaluation, Session 20 (Week 15): Follow-up Evaluation
The COPM is a patient-reported outcome measure in which the participant will be asked to rate their ability to perform tasks of everyday living. Specifically, the assessment asks participants to identify tasks that they find value in completing, rank their priority, and rank their ability to perform them.
次要结局
- Motor evoked potential status (MEPs)(Session 2 (Week 1): Baseline Evaluation, Session 19 (Week 7): Post-intervention Evaluation, Session 21 (Week 15): Follow-up Evaluation)
- Maximum Voluntary Contraction (MVC)(Session 2 (Week 1): Baseline Evaluation, Session 19 (Week 7): Post-intervention Evaluation, Session 21 (Week 15): Follow-up Evaluation)
- H-reflex(Session 2 (Week 1): Baseline Evaluation, Session 19 (Week 7): Post-intervention Evaluation, Session 21 (Week 15): Follow-up Evaluation)
研究者
Mary Ellen Stoykov
Research Scientist, Principal Investigator
Shirley Ryan AbilityLab